RxSight Light Adjustable Lens (RxLAL)

GUDID 00818806020562

LAL, Sterile, Packaged, 12.0 Diopter

RXSIGHT, INC.

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic
Primary Device ID00818806020562
NIH Device Record Keyd0013ade-17a8-47a4-a651-ec8bb542f825
Commercial Distribution StatusIn Commercial Distribution
Brand NameRxSight Light Adjustable Lens (RxLAL)
Version Model Number60005-3120
Company DUNS052054413
Company NameRXSIGHT, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100818806020562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZKLight Adjustable Lens (Lal) And Light Delivery Device (Ldd)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-23
Device Publish Date2021-06-15

On-Brand Devices [RxSight Light Adjustable Lens (RxLAL)]

00818806020319LAL, Sterile, Packaged, 30.0 Diopter
00818806020302LAL, Sterile, Packaged, 29.0 Diopter
00818806020296LAL, Sterile, Packaged, 28.0 Diopter
00818806020289LAL, Sterile, Packaged, 27.0 Diopter
00818806020272LAL, Sterile, Packaged, 26.0 Diopter
00818806020265LAL, Sterile, Packaged, 25.0 Diopter
00818806020258LAL, Sterile, Packaged, 24.0 Diopter
00818806020241LAL, Sterile, Packaged, 23.5 Diopter
00818806020234LAL, Sterile, Packaged, 23.0 Diopter
00818806020227LAL, Sterile, Packaged, 22.5 Diopter
00818806020210LAL, Sterile, Packaged, 22.0 Diopter
00818806020203LAL, Sterile, Packaged, 21.5 Diopter
00818806020197LAL, Sterile, Packaged, 21.0 Diopter
00818806020180LAL, Sterile, Packaged, 20.5 Diopter
00818806020173LAL, Sterile, Packaged, 20.0 Diopter
00818806020166LAL, Sterile, Packaged, 19.5 Diopter
00818806020159LAL, Sterile, Packaged, 19.0 Diopter
00818806020142LAL, Sterile, Packaged, 18.5 Diopter
00818806020135LAL, Sterile, Packaged, 18.0 Diopter
00818806020128LAL, Sterile, Packaged, 17.5 Diopter
00818806020111LAL, Sterile, Packaged, 17.0 Diopter
00818806020104LAL, Sterile, Packaged, 16.5 Diopter
00818806020098LAL, Sterile, Packaged, 16.0 Diopter
00818806020081LAL, Sterile, Packaged, 15.0 Diopter
00818806020074LAL, Sterile, Packaged, 14.0 Diopter
00818806020067LAL, Sterile, Packaged, 13.0 Diopter
00818806020050LAL, Sterile, Packaged, 12.0 Diopter
00818806020043LAL, Sterile, Packaged, 11.0 Diopter
00818806020036LAL, Sterile, Packaged, 10.0 Diopter
00818806020944LAL, Sterile, Packaged, 9.0 Diopter
00818806020937LAL, Sterile, Packaged, 8.0 Diopter
00818806020920LAL, Sterile, Packaged, 7.0 Diopter
00818806020913LAL, Sterile, Packaged, 6.0 Diopter
00818806020906LAL, Sterile, Packaged, 5.0 Diopter
00818806020890LAL, Sterile, Packaged, 4.0 Diopter
00818806020821LAL, Sterile, Packaged, 16.0 Diopter
00818806020814LAL, Sterile, Packaged, 30.0 Diopter
00818806020807LAL, Sterile, Packaged, 29.0 Diopter
00818806020791LAL, Sterile, Packaged, 28.0 Diopter
00818806020784LAL, Sterile, Packaged, 27.0 Diopter
00818806020777LAL, Sterile, Packaged, 26.0 Diopter
00818806020760LAL, Sterile, Packaged, 25.0 Diopter
00818806020753LAL, Sterile, Packaged, 24.0 Diopter
00818806020746LAL, Sterile, Packaged, 23.5 Diopter
00818806020739LAL, Sterile, Packaged, 23.0 Diopter
00818806020722LAL, Sterile, Packaged, 22.5 Diopter
00818806020715LAL, Sterile, Packaged, 22.0 Diopter
00818806020708LAL, Sterile, Packaged, 21.5 Diopter
00818806020692LAL, Sterile, Packaged, 21.0 Diopter
00818806020685LAL, Sterile, Packaged, 20.5 Diopter

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